Drug – bio-affecting and body treating compositions – Manicure or pedicure compositions
Reexamination Certificate
1998-05-19
2001-05-15
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Manicure or pedicure compositions
C424S061000, C424S405000
Reexamination Certificate
active
06231840
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to compositions and methods for treating keratinous tissue for purposes of straightening hair, enhancing curl retention of hair, treating nail fungal conditions, including onychomycosis, ingrown nails, hyperkeratotic conditions, including psoriasis, acne and keratosis pilaris, callouses, corns, plantar wart, Dowling-Meara form of epidermolysis bullosa simplex, ichthyosiform dermatoses, and surface lines and blemishes of aging skin by exfoliation of keratinocytes.
BACKGROUND OF THE INVENTION
Hair Treatment
Human hair is a thermoset of cross-linked, &agr;-helix protein, primarily keratin. Keratin is composed of a complex of polypeptide chains of high molecular weight. Protein sequencing analysis of whole hair fiber using acid hydrolysis has found traces of all the amino acids in human hair, but suggests that cystine, glutamic acid, serine, leucine, aspartic acid, arginine and threonine are among the amino acids of highest prevalence in hair.
1
The human hair shaft is comprised of three concentric layers identified as the cuticle, a thin, outer-most shell, the cortex, the main body of the hair, and the medulla, a thin, central core. The cuticle and cortex are responsible for the hair shaft's mechanical properties (in some hair the medulla is absent). The cuticle is composed of flattened, scale-like platelets of amphoras keratin. Its condition is responsible for the outward appearance of the hair, particularly feel and shine. The cortex forms and is composed of long keratinous spindle cells containing numerous macrofibrils of intermediate filament protein, held together by an intercellular matrix of beta-keratose. Each macrofibril contains 11 protofibrils in a helical structure. Each of the protofibrils is composed of three alpha-helices, the fundamental fibrous keratin.
1
Gillespie and Inglis,
Total S
-
Carboxymethyl Keratin Extracted from Guinea Pig Hair by Standard Methods
(1965).
Alpha-helical keratin maintains its coil-shaped secondary structure by the use of hydrogen bonding between adjacent turns of the coil and by ionic bonding or salt bridges which pair the amine bases, lysine and arginine to the carboxylic acids, aspartic acid and glutamic acid. The method described herein changes the charge on the carboxylic acids within keratin causing both the loss of hydrogen bonding properties and the cleavage of the salt bridges. Secondary to these events is the disassociation of some of the disulfide bridges, or cystine bonds from the helix structure itself which are a principle force in the maintenance of natural curl. With the loss of hydrogen and ionic bonding, the keratin is partially denatured. The shaft becomes less sensitive to external moisture and more sensitive to heat-induced curling. With the partial loss of secondary and tertiary structure involving disulfide bridges, naturally curly hair loses its wavyness.
Those amino acids which are affected by the electron protonation of weak carboxylic acids (aq) resulting from the protonation of glutamic acid and aspartic acid are marked below by an asterisk.
The Amino Acid Composition of Hair Follicle Proteins (residues per
1000 amino acid residues)
2
Amino Acid
Residues
Cys
160*
Asp
52*
Thr
59
Ser
97
Glu
127*
Pro
52
Cit
0
Gly
50
Ala
54
Met
0
Ile
31
Leu
64
Tyr
30
Phe
43
Lys
24*
His
12
Arg
71*
Isopeptide
Trace
2
Gillespie and Inglis, 1965, total S-carboxymethyl keratin extracted from guinea pig hair by standard methods.
Hair can be divided into four conformational categories: (i) straight, (ii) wavy, (iii) curly, and (iv) kinky. The amount of curl is directly associated with two factors: the alignment and shape of the follicle in the epidermis (the more angulated the follicle the more curly) and the shape of the shaft itself Straight hair resembles a rod with a circular diameter; wavy hair shafts are compressed into an oval diameter; curly shafts are further compressed into an elongated ellipse and kinky hair shafts are flatter still. Hair shaft configurations are as follows:
Straight
Wavy
Curly
Kinky
The elastic behavior of most hair types when wet is due to the hydrogen bonding that occurs between adjacent coils of keratin's secondary &agr;-helix structure.
3
Hair becomes straighter when wet because hydrogen bonds—connecting the amino group of one amino acid and the oxygen of the third amino acid beyond it—are easily broken in water. The polypeptide chain can then be pulled out of its compact helical shape into a more extended form. As the hair dries the hydrogen bonds reform and the chains contract into their normal length. A similar, reversible breaking of hydrogen bonds occurs when hair is subject to tension or heat, as demonstrated by heat curlers, heat wands and heat combs. Keeton et al. describe the rubberband-like hydrogen bonds of &agr;-helix keratin coils.
4
3
Knowlton, John,
Handbook of Cosmetic Science and Technology
, Justine-Avon Pty, South Africa. Excerpted from the chapter, The Structure of Hair, Cosmetic Science & Technology On-Line contents page.
4
Keeton, W. T., Gould, J. L.,
Biological Science,
5th Ed., W.W. Norton, New York, 1993, p. 67.
To permanently alter the natural curl or straightness of human hair, a number of types of bonds must be cleaved, including salt bridges and disulfide bonds.
5
Disulfide bridges (cystine bridges) often serve to attach separate keratin strands or hold the strand within the surrounding matrix. Current permanent waving and straightening methods break disulfide bonds into free sulfhydryls and then re-establish new disulfide bonds in the desired configuration by reduction/oxidation of the hair shaft using various chemicals sequentially. This manipulation of sulfur (S) within cysteine is possible by alkalis, bisulfides and other chemicals because cystine's small, aliphatic side chains contain polar groups that ionize readily. Nevertheless, the process is harsh on the hair and potentially harmful to the skin.
5
Menefee, E., Relation of keratin structure to its mechanical behavior,
Appl. Polymer Symposium,
18, 809-821.
Disulfide bridges are most predominant in the outermost layer of the shaft's cuticle, the epicuticle, with progressively less found in the cuticle's sublayers, the exocuticle and endocuticle. The epicuticle also contains more disulfide bonds than does the matrix of the cortex.
6
6
The amount of cysteine and sulfur in tissue determines its hardness—tortoise shells, hooves, and horns are examples of the strength derived from cysteine bridges when up to one amino acid in four is cysteine. Keeton, W T, Gould, J. L.,
Biological Science,
5th Ed., WW Norton, New York, 1993., p. 67.
Current Methods of Permanent Hair Waving and Relaxing. New mechanical structure is imposed on hair shafts on a semi-permanent basis by the use of several types of chemicals capable of cleaving and reforming disulfide bonds in a two step process (reduction and oxidation) that results in the temporary denaturing of hair protein.
7
Several formulation improvements and additives have been developed in an effort to reduce the harshness of these chemicals and maintain pliable hair properties. Current methods, however, remain dangerous to the skin and eyes. Direct contact can result in second- and third-degree chemical burns or even hair loss.
8
None of the known methods are recommended if the scalp or skin is sensitive, scaly, scratched, sore or tender, and unsatisfactory, sometimes harmful results occur if the directions are not carefully followed.
7
Biochemistry
2001:
Introductory Biochemistry
, Mount Allison University, Dr. A. Cockshutt (1997);
Protein Function: Folding of Structural proteins: Course Outline and Lecture Notes, Winter Term
1997.
8
The A.M.A. Book of Skin and Hair Care
, Schoen, L A, Ed., American Medical Association, J.B. Lippincott Company, NY, 1976. p. 116.
During the permanent wave or straightening process, the hair is reshaped into waves with appliances or pulled straight by combing with lotions containing reducing agents. After 10 to 20 minutes,
Howard Sharon
Mathews, Collins Shepherd & Gould P.A.
Page Thurman K.
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